1. Scope of the EU Machinery Directive
The EU Machinery Directive does not focus on technical details, but rather on safety and health regulations related to machine design and mechanisms. The current Machinery Directive (98/37/EC, published in the Official Journal of the European Union on July 23, 1998) replaces Directive 89/392/EEC (1989) and its subsequent amendments 91/368/EEC, 93/44/EEC, and 93/63/EEC. Since January 1, 1995, the Machinery Directive has been mandatory in Europe, and all EU member states are required to incorporate some of its basic provisions into their national laws.
EU Machinery Directive 98/37/EC applies to a wide range of machinery and safety components sold on the market, but not to certain specific types of machinery. The complete regulations of the Machinery Directive, including the issuance of declarations of conformity and the application of the CE marking, also apply to used or refurbished machinery, including used or refurbished new machinery imported into the region for the first time from countries outside the EU and the European Economic Area. New machinery, disassembled and reassembled from around the world, presents new designs and new risks.
1) "Machinery" as defined in the Machinery Directive
Machinery as defined in the Machinery Directive includes single machines, connected groups of machines, and interchangeable equipment.
1) Machinery refers to an assembly of several connected parts, at least one of which is movable and connected by appropriate brakes, control devices, and power circuits, and has a specific purpose, such as the processing, handling, transportation, and packaging of materials. It mainly includes the following categories of products: woodworking machinery, metal cutting machine tools, forging machinery, agricultural and forestry tractors and their auxiliary machinery, rubber and plastic machinery, packaging machinery, lifting and transport machinery, storage equipment, construction machinery, food processing machinery, heat treatment equipment, underground mining machinery, printing and papermaking machinery, casting machinery, textile machinery, washing machinery, compressors, internal combustion engines, pumps, leather tanning machinery, fire-fighting equipment, etc. Machinery that is packaged and transported in disassembled form for ease of transport, but is reassembled for use, should also comply with this directive.
2) A combination of machines, where several machines are appropriately configured and controlled to achieve a single purpose, forming a complete whole. Examples include automated production lines and flexible manufacturing systems.
3) Replaceable equipment refers to equipment whose functions can be changed and which is detachable and replaceable. This equipment is marketable and can be assembled by the operator with one or more different machines or traction machines. This equipment is not a spare part or tool. This equipment may be self-powered, such as a face-mounted device on a machine tool.
Safety components in the Machinery Directive are not the aforementioned replaceable equipment. They are components marketed by the manufacturer or its authorized agents within the European Community that provide a safety function in use. Their failure or malfunction could endanger the safety or health of the exposed person (here, "exposed person" refers to any person who is wholly or partially in a danger zone). Examples include: lifting ropes, emergency stop devices, logic elements ensuring two-handed control, electronically sensitive devices designed to protect personnel, fall protection devices, and overload protection devices.
2) Machinery Not Subject to the Machinery Directive
The term "machinery" encompasses any type of equipment, whether for domestic, commercial, or industrial use, containing parts that are operated by electricity rather than human power. However, there are exceptions; some machinery is not included in the Machinery Directive but its risks are covered by other directives. For example, when the risk of machinery relates to electricity, it is included in the Low Voltage Directive (73/23/EEC). Such machinery is already included in the Low Voltage Directive standards published in the Official Gazette.
Specifically, the following machinery is unsuitable for the Machinery Directive:
Machinery powered solely by human labor, except for machinery used for lifting and lowering loads; medical devices that come into direct contact with patients;
Specialized equipment in markets and/or amusement parks; steam boilers, tanks, and pressure vessels;
Machinery specifically designed or used for nuclear purposes, which, in the event of a malfunction, would result in radioactive radiation; radioactive sources formed by mechanical parts;
Light weapons; storage tanks for gasoline, diesel, flammable liquids, and hazardous substances; nuclear transport pipelines;
Mechanisms of transport, referring to those used to transport passengers via public transportation networks such as air, road, rail, and water. This includes passenger vehicles and their trailers, as well as devices used to transport goods via transportation networks such as air, road, rail, and water. Vehicles used in mining are not exempt;
Ocean-going vessels and offshore motorized equipment, together with the equipment thereon; public or private ropeways (including cable cars);
Tractors used in agriculture and forestry as defined in Article 1(1) of Directive 74/150/CEE (on the harmonization of the laws of the Member States concerning the designation of wheeled agricultural or forestry tractors);
Machinery designed and manufactured for military or police use;
Permanent lifting equipment for a specific height of a building, having a trolley that moves between rigid guide rails at an angle greater than 15 degrees to the horizontal, designed to carry:
1) personnel
2) personnel and goods
3) goods, but the trolley can be entered, i.e., a person can easily enter the trolley, and the control is located inside the trolley or within the reach of a person inside the trolley;
Personnel transport devices using vehicles equipped with gears and racks; mine hoists; stage lifts; construction site lifts for transporting people or people and goods.
Is a CD player considered machinery because it has moving parts? Of course not. Many products, while having moving parts in various forms, are not included in the scope of the directive. Furthermore, "movement" must be caused by external kinetic energy (electricity, batteries, fuel, etc.) or stored energy (springs, weight). In addition to this requirement, the Machinery Directive also covers certain lifting equipment directly driven by human power. Other machinery directly driven by human power is not included. Moreover, the main risk posed by the product must be mechanically powered rather than electrically powered.
2. Products Requiring EC Declaration of Conformity and CE Marking
For products covered by the Machinery Directive, the CE marking is mandatory. CE stands for Conformity European. Before legally affixing the CE marking to a machine, the manufacturer must issue a Declaration of Conformity (Doc), a formally signed document indicating compliance with the basic requirements of all applicable directives. The CE marking represents compliance with legal regulations; it is neither a quality mark nor a safety mark. The CE marking can be placed on the machine along with third-party safety marks to demonstrate the manufacturer's commitment to integrity. Without the CE marking, a product cannot be placed on the market or used in the EU and the European Economic Area if it fails to comply with the requirements of the directives. However, if the product complies with the applicable EU directives, it will not be prohibited, restricted, or blocked by these countries. Therefore, the CE marking is considered a "passport" for products to circulate in Europe.
Product Category
EC Declaration of Conformity
CE Mark
Machinery (including single machines, machine combinations, and interchangeable parts)
Requirements
Requirements
Safety components, machinery that cannot operate independently when incorporated into another machine
Requirements
Not Required
3. Requirements for Preparing an EC Declaration of Conformity
1) Annex II of the Directive specifies the contents that an EC Declaration of Conformity should include, generally including the following:
The name and address of the manufacturer or its authorized agent within the European Community; information regarding the product's construction, type, serial number, etc.;
The relevant directive to which the product conforms; where necessary, the standards adopted;
Where necessary, the name, address, and relevant certification matters of the notified body; the identity and signature of the manufacturer's representative or its authorized agent within the European Community;
For machinery that cannot operate independently and will be incorporated into another machine, the declaration should also state that "the machine shall not be used until it is incorporated into the corresponding machine and has not yet conformed to this Directive."
2) The EC Declaration of Conformity must be prepared in the same language as the machine's description. A translation in the official language of the country where the machine will be used should be attached. The Declaration of Conformity should be printed and legible.
4. Annex I: The Core of the Machinery Directive
For manufacturers, Annex I is the core and essence of the Machinery Directive. Annex I not only broadly lists potential hazards arising from design and operation, but also provides general guidelines for avoiding those hazards. The basic provisions listed in the Machinery Directive are as follows:
Basic health and safety provisions; additional basic health and safety provisions for certain types of machinery (agricultural machinery, light hand-held and/or manual machinery, wood and similar material processing machinery);
Basic health and safety provisions for eliminating particular hazards caused by mechanical traction; basic health and safety provisions for eliminating particular hazards caused by lifting operations; basic health and safety provisions applicable to machinery used for underground operations;
5. Standards: Tools for Demonstrating Compliance with the Directive
Compliance with applicable harmonized EU standards is the recommended method for achieving the basic health and safety provisions of the Machinery Directive. These standards play a crucial role in the implementation of EU directives; all directives are presumed to be compliant with the directives by referring to so-called "harmonized" European standards. Harmonized standards related to the directives must be published in the Official Journal of the European Union.
The European Committee for Standardization (CEN) is working to develop a comprehensive set of European standards covering three categories to support the Machinery Directive. Category A standards include general principles for the design of various types of machinery (e.g., EN 292 Mechanical Design, or EN 1050 Risk Assessment).
Category B standards cover the ergonomics of specific safety devices and types of machinery (e.g., EN 418 Emergency Stop Devices, or EN 574 Two-Handed Control).
Finally, Category C standards cover specific machinery classifications that reference the first two categories, emphasizing the requirements for that specific machinery (e.g., EN 201 for injection molding machinery, or EN 474 for bulldozing machinery). To date, most Category A and B standards have been published, but approximately 600 technical committees and working groups are still working on Category C standards, prioritizing machinery in Annex IV. It is estimated that it will take several more years for all Category C standards to be published. Meanwhile, compliance with the basic requirements of the regulation can be demonstrated through Category A and B standards and the adoption of most general product standards. The following are the main harmonized standards of the Machinery Directive:
EN 292-1,-2: Safety of machinery – Basic concepts, general principles of design
EN 1050: Safety of machinery – Principles of risk assessment
EN 60204-1: Safety of machinery – Electrical equipment for machinery
EN 954-1: Safety of machinery – Safety components for control systems
EN 294: Safety of machinery – Safety distances
EN 349: Minimum clearance for preventing pinching injuries
EN 418: Safety of machinery – Emergency stop
EN 1088: Safety of machinery – Interlocking devices
EN 775: Automated machinery
6. Machinery and safety components that must undergo EC type testing by a notified body
Broadly speaking, the Machinery Directive classifies machinery into two main categories: hazardous machinery and ordinary machinery. High-potential-hazard machinery and selected safety components are listed in Annex IV of the Machinery Directive. These products are subject to special regulations. For the machinery listed in Annex I, manufacturers must involve a notified body (generally, the notified body will issue an EC type test certificate) before affixing the CE marking. All other machinery must comply with the essential health and safety requirements of Annex I, but manufacturers or importers may also conduct their own conformity assessments. The manufacturer must then submit a technical file, a declaration of conformity, and affix the CE marking.
The following are the machinery and safety components that must undergo EC type testing by a notified body:
A. Machinery
1. Single-blade or multi-blade circular saws for processing timber and similar materials or meat and similar materials
Circular saws in which the saw blade does not move during operation, and the machine is powered by a fixed bed, using manual feeding or detachable power feeding;
Circular saws in which the saw blade does not move during operation, and the machine uses a manually operated reciprocating worktable or bracket for feeding;
Circular saws in which the saw blade does not move during operation, but has an internal mechanical workpiece feeding device, and uses manual loading and/or unloading;
Circular saws in which the saw blade moves during operation, has a mechanical feeding device, and uses manual loading and/or unloading.
2. Hand-feed woodworking surface planer;
3. Hand-loading woodworking single-sided planer;
4. Band saw for processing wood and similar materials or meat and similar materials, with a fixed or movable bed (carriage) or movable bracket, and hand-loading and/or unloading;
5. Combination machine tools for processing wood and similar materials listed in Sections 1 to 4 and 7 of this section;
6. Woodworking tenoning machine with multi-blade clamp and hand-feed;
7. Vertical spindle die-making machine for processing wood and similar materials;
8. Hand-held chainsaw for woodworking;
9. Press for cold working of metals, including bending machines, with a stroke greater than 6 mm, a speed greater than 30 mm/s, and hand-loading and/or unloading;
10. Plastic injection or extrusion molding machine with hand-loading and/or unloading;
11. Rubber injection or extrusion molding machine with hand-loading and/or unloading; 12. The following types of underground working machinery:
Railway machinery: locomotives and refrigerated cars;
Hydraulic roof support machinery;
Internal combustion engines for underground working machinery.
13. Manual loaders equipped with compression devices for collecting household waste;
14. Protective devices as described in Clause 3.4.7 of Annex I and detachable rotating shafts with universal joints;
15. Lifting vehicles;
16. Personnel lifts with a vertical height exceeding 3m and a risk of fall;
17. Machinery for producing fireworks;
B. Safety Components
1. Electronically sensitive devices (non-material barriers, sensitive components, electromagnetic testers, etc.) specially designed to ensure personnel safety;
2. Logic devices with two-hand control to ensure safety functions;
3. Automated movable isolation barriers involving press protection as described in Clauses 9, 10, and 11 of Part A of this Appendix;
4. Rollover protection devices (ROPS);
5. Falling object protection devices (FOPS). 7. Hazard Analysis and Risk Assessment
Under the Machinery Directive, the manufacturer's primary obligation is to conduct hazard analysis and risk assessment. Hazard analysis involves using instruments to identify hazards in the machinery at different applicable life stages and to take preventative measures where necessary. Risk assessment is...
